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Generated: December 13, 2017

DrugPatentWatch Database Preview

BREO ELLIPTA Drug Profile

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Which patents cover Breo Ellipta, and what generic alternatives are available?

Breo Ellipta is a drug marketed by Glaxo Grp Ltd and is included in one NDA. There are fourteen patents protecting this drug.

This drug has three hundred and sixty-eight patent family members in forty-two countries and twenty-six supplementary protection certificates in fourteen countries.

The generic ingredient in BREO ELLIPTA is fluticasone furoate; vilanterol trifenatate. There are twenty-five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the fluticasone furoate; vilanterol trifenatate profile page.

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Glaxo Grp LtdBREO ELLIPTAfluticasone furoate; vilanterol trifenatatePOWDER;INHALATION204275-002Apr 30, 2015RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Glaxo Grp LtdBREO ELLIPTAfluticasone furoate; vilanterol trifenatatePOWDER;INHALATION204275-002Apr 30, 2015RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Glaxo Grp LtdBREO ELLIPTAfluticasone furoate; vilanterol trifenatatePOWDER;INHALATION204275-002Apr 30, 2015RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Glaxo Grp LtdBREO ELLIPTAfluticasone furoate; vilanterol trifenatatePOWDER;INHALATION204275-002Apr 30, 2015RXYesYes► Subscribe► Subscribe► SubscribeYY► Subscribe
Glaxo Grp LtdBREO ELLIPTAfluticasone furoate; vilanterol trifenatatePOWDER;INHALATION204275-002Apr 30, 2015RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Glaxo Grp LtdBREO ELLIPTAfluticasone furoate; vilanterol trifenatatePOWDER;INHALATION204275-001May 10, 2013RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Glaxo Grp LtdBREO ELLIPTAfluticasone furoate; vilanterol trifenatatePOWDER;INHALATION204275-001May 10, 2013RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Glaxo Grp LtdBREO ELLIPTAfluticasone furoate; vilanterol trifenatatePOWDER;INHALATION204275-001May 10, 2013RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Glaxo Grp LtdBREO ELLIPTAfluticasone furoate; vilanterol trifenatatePOWDER;INHALATION204275-002Apr 30, 2015RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Glaxo Grp LtdBREO ELLIPTAfluticasone furoate; vilanterol trifenatatePOWDER;INHALATION204275-001May 10, 2013RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
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Expired Patents for Tradename: BREO ELLIPTA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxo Grp LtdBREO ELLIPTAfluticasone furoate; vilanterol trifenatatePOWDER;INHALATION204275-001May 10, 2013► Subscribe► Subscribe
Glaxo Grp LtdBREO ELLIPTAfluticasone furoate; vilanterol trifenatatePOWDER;INHALATION204275-002Apr 30, 2015► Subscribe► Subscribe
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Non-Orange Book Patents for Tradename: BREO ELLIPTA

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,125,985Compounds useful in the manufacture of an anti-inflammatory androstane derivative► Subscribe
7,541,350Formulation containing anti-inflammatory androstane derivative► Subscribe
6,750,210 Formulation containing novel anti-inflammatory androstane derivative► Subscribe
7,132,532Compounds useful in the manufacture of an anti-inflammatory androstane derivative► Subscribe
9,636,471Medicament dispenser► Subscribe
7,592,329Crystalline complexes of fluticasone-2-furoate► Subscribe
7,144,845Compounds useful in the manufacture of an anti-inflammatory androstane derivative► Subscribe
6,858,596 Formulation containing anti-inflammatory androstane derivative► Subscribe
6,787,532 Formulation containing anti-inflammatory androstane derivatives► Subscribe
7,498,32117.beta.-carbothioate 17.alpha.-arylcarbonyloxyloxy androstane derivative as anti-inflammatory agents► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: BREO ELLIPTA

Country Document Number Estimated Expiration
Australia2003244450► Subscribe
European Patent Office1467790► Subscribe
Japan2012254315► Subscribe
Japan4508651► Subscribe
China1622838► Subscribe
Portugal1730676► Subscribe
Japan2005515039► Subscribe
Israel177042► Subscribe
United Kingdom0418264► Subscribe
World Intellectual Property Organization (WIPO)2007012871► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: BREO ELLIPTA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
4 50004-2014Slovakia► SubscribePRODUCT NAME: VILANTEROLTRIFENATAT; REGISTRATION NO/DATE: EU/1/13/886/001 - EU/1/13/886/006 20131113
C/GB08/026United Kingdom► SubscribePRODUCT NAME: FLUTICASONE FUROATE AND SOLVATES THEREOF; REGISTERED: UK EU/1/07/434/001 20080111; UK EU/1/07/434/002 20080111; UK EU/1/07/434/003 20080111
C0014France► SubscribePRODUCT NAME: FLUTICASONE FLUORATE; REG. NO/DATE: EU/1/07/434/001 20080111
2014 00021Denmark► SubscribePRODUCT NAME: VILANTEROL ELLER ET SALT ELLER SOLVAT DERAF, HERUNDER VILANTEROL TRIFENATAT; REG. NO/DATE: EU/1/13/886/001-006 20131113
00664Netherlands► SubscribePRODUCT NAME: VILANTEROL, DAN WEL EEN ZOUT OF SOLVAAT DAARVAN, IN HET BIJZONDER HET TRIFENYLACETAATZOUT; REGISTRATION NO/DATE: EU/1/13/886/001-006 20131113
439Luxembourg► SubscribePRODUCT NAME: VILANTEROL OU UN SEL OU UN SOLVATE DE CELUI-CI
C0067France► SubscribePRODUCT NAME: AZELASTINE OU SES SELS PHARMACEUTIQUEMENT ACCEPTABLES ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE; NAT. REGISTRATION NO/DATE: NL41755 20130925; FIRST REGISTRATION: SK - 24/0055/13-S 20130215
1305329/01Switzerland► SubscribePRODUCT NAME: FLUTICASON FUROAT; REGISTRATION NUMBER/DATE: SWISSMEDIC 57968 19.12.2007
12/2008Austria► SubscribePRODUCT NAME: FLUTICASON FUROAT UND DESSEN SOLVATE
2008 00022Denmark► Subscribe
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Serving leading biopharmaceutical companies globally:

Deloitte
Accenture
Harvard Business School
Mallinckrodt
Citi
Colorcon
Boehringer Ingelheim
Federal Trade Commission
Cipla
Fish and Richardson

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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